ISO 15189: 2012 Certification for COVID 19 Testing Laboratories
The Novel Coronavirus has caused a global pandemic that has affected every country in the world. So far millions of people have been infected and several million have died globally. Every day hundreds of thousands of people are getting infected and thousands are dying due to this disease. Till now, there is no cure or vaccine has been discovered for this Coronavirus and the researches are still going on. Until the vaccine is discovered, the prevention and detection of infections at the right is the only way to control the spread of the disease. As this is a very sudden situation, there are very few labs that are capable and authorized to conduct the COVID-19 testing.
There is a need for a larger number of COVID 19 labs to increase the reach of testing for COVID 19 so that the spread of the disease could be done in a controlled manner. To set up a COVI 19 testing lab, there are many different things to be considered. There are different guidelines to be followed by COVID 19 testing labs on how to conduct different types of tests for COVID 19, how to collect test samples from the patients, and declaring the test results.
Two different types of tests are commonly used for the diagnosis of COVID 19 infection. One is the Real-Time Polymerase Chain Reaction test or RTPCR test and the other one is the Antigen Test.
The testing is done by taking a sample from the respiratory channel which is called a nasopharyngeal sample which is taken from the throat behind the nose. In some cases, the cheek swab is also used for testing. The time taken from the test ranges from fifteen minutes to three days the type of test being conducted. RTPCR takes less time to give results but the antigen and antibody test takes one to three days to be finalized.
TO conduct both RTPCR and Antigen test, there is a proper protocol set by the CDC and ICMR that must be followed. To set up a COVID 19 testing laboratory, one needs to have a proper infrastructure along with all the prescribed protection measures such as personal protective kits, masks, face shields, and hand gloves. There must be a proper waiting space dedicated to the patients for waiting and testing. A well-qualified team of lab technicians and pathologists should monitors and conduct every step for COVID 19 testing. The ISO 15189: 2012 certification and NABL accreditation is also mandatory for the labs as per the regulations set by NABL and ICMR. These certifications and accreditations imply that the lab is competent enough to maintain the credibility and accuracy of the test results conducted in the facility.
IF you are also looking for guidance to set up a COVID 19 testing laboratory, then Primecertification can be of your assistance. We have a vast team of well-qualified professionals that can handle all the formalities required for ISO 15189: 2012 certification as well as NABL accreditation. In addition to that, we also provide consultancy for setting up the infrastructure for the COVID 19 testing labs. With our guidance and assistance, our clients can have a successful establishment of their labs with less hassle and complete pace of mind.